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ALS stem cell study halted after just one patient

NCT ID NCT06910384

Disease control Sponsor: New England Cell Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a single dose of STR04, made from a patient's own bone marrow stem cells, for amyotrophic lateral sclerosis (ALS). Only one person enrolled before the study was stopped early. The goal was to see if the treatment was safe and could slow the disease, but no conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous bone-marrow-derived mesenchymal stem cells
What this could lead to
If successful, this approach could point toward a treatment to slow ALS progression.
What could go wrong
The trial was terminated early with only 1 participant, so results are not reliable. Stem cell treatments for ALS remain unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

1 person

The number who actually took part.

Started

Aug 2025

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion: * "Definite" or "Probable" ALS according to the Revised El Escorial criteria (Airlie House) * ALS severity grade 1 or 2 according to the Japan ALS severity classification. * ALSFRS-R scores of 2 or more for all items, with scores of 4 for all breathing- related items (i.e., dyspnea, orthopnea, respiratory insufficiency). * Within 2 years of ALS onset. * %FVC of 80% or more. * Aged 18 to ≤75 years at the time of informed consent. Exclusion: * Current Viral Infection (e.g. HBV, HCV, HIV, HTLV-1, HPVB19, syphilis, COVID- 19). * Current low blood cell counts * History of cancer, congenital malformations, or chromosomal abnormalities * History of allergy to penicillin or streptomycin, or other serious allergies. * Current poor medical condition, due to endocrine disease, metabolic disease, immune disease, blood disease, psychiatric disorders, neurological diseases, cardiovascular diseases, respiratory diseases, gastrointestinal diseases, musculoskeletal or connective tissue diseases, renal or urogenital diseases. * History of intracranial lesions, or stenosis, dissection or severe atherosclerotic disease of a blood vessel in the head or neck. * Current uncontrolled hypertension. * Prior treatment with a cell or gene therapy. * Currently participating in any other clinical trial. * Women who are pregnant, breastfeeding, or plan to become pregnant during study participation * Men with plan for their partner to become pregnant during study participation.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis

Contacts and locations

Locations

  • National Neuromuscular Research Institute

    Austin, Texas, 78759, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.